European Council’s recommendations on R&I
by Giuliana Miglierini The end of 2023 saw some steps forward to better support the European framework on…
The risk of a biosimilar void in Europe
by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to…
EP’s draft position on Unitary SPC and SPC Regulation revision
by Giuliana Miglierini The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to…
EC Communication (part 2): a Critical Medicines Alliance to support European pharma supply chain
by Giuliana Miglierini After last week’s examination of the first part of the Commission’s Communication, specifically targeted to…
EC Communication (part 1): How to address critical medicines shortages
by Giuliana Miglierini As announced on 3 October in the speech given by Commissioner Stella Kyriakides at European…
The UK’s statutory scheme revision for branded medicines
by Giuliana Miglierini The amendment of the statutory schemeregulating the increase in pricing and consequent clawback payments of…